MDR Article 22 applicability - Legal manufacturer

#1
Hello,

I was hoping if you can help me come to a resolution on a question I have been pondering for some months.

We are a legal manufacturer of a Class III and a Class IIb (MDR) medical devices. Both are required to work together to ensure the intended purpose is met, and we as the legal manufacturer have designed and validated the products to work together. The Class III has multiple reuses and the Class IIb is a consumable part. Both have separate CE marks, conformity assessments and DOCs.

Both products have their own UDIs, one part must be always placed on the market with the consumable and the consumable can be sold on its own.

Where I keep pondering is does Article 22 actually apply to us as the legal manufacturer (LM).

My current assessment is no, for these reasons;
1. Products have been designed and validated to work together by LM​
2. All packaging and labelling etc dictates that both products are required to be used for the 'system' to meet its intended use​
3. Both products already have their UDIs, and we wouldn't be able to apply two Basic UDI-DI to the same single UDIs​
4. It doesn't seem right that the LM would need a SRN for the legal manufacturing activity plus system producer (terminology from MDCG 2018-3, Oct-2018)​
5. I read a good position statement online that referred back to a ruling by a German regional council looking at a similar situation in Germany, where they didn't have to prepare the combination statement (MDD Art 12) because the products have already undergone conformity assessment by the NB. Thus they consider the declaration as the party for assembly of the system necessary only if they are not the legal manufacturer.​
What I am trying to avoid is putting another UDI on the box in which the product is supplied to the customer in.

Does anybody have experience with Article 22? or agreement/disagreement with my assessment above.
Really appreciate any help,
Alice
 
Elsmar Forum Sponsor

dgrainger

Trusted Information Resource
#6
Hi,
It isn't clear if someone is placing the devices on the market as a 'system/procedure pack' nor if it is you or someone else doing this. Could you clarify?
 
#7
Hi,
It isn't clear if someone is placing the devices on the market as a 'system/procedure pack' nor if it is you or someone else doing this. Could you clarify?
Hi dgrainger, we the legal manufacturer are putting both parts on the market, currently not as a system or PP, but I am trying to understand if it should be a system. I hope that clarifies :)
 
#8
Hello,

I was hoping if you can help me come to a resolution on a question I have been pondering for some months.

We are a legal manufacturer of a Class III and a Class IIb (MDR) medical devices. Both are required to work together to ensure the intended purpose is met, and we as the legal manufacturer have designed and validated the products to work together. The Class III has multiple reuses and the Class IIb is a consumable part. Both have separate CE marks, conformity assessments and DOCs.

Both products have their own UDIs, one part must be always placed on the market with the consumable and the consumable can be sold on its own.

Where I keep pondering is does Article 22 actually apply to us as the legal manufacturer (LM).

My current assessment is no, for these reasons;
1. Products have been designed and validated to work together by LM​
2. All packaging and labelling etc dictates that both products are required to be used for the 'system' to meet its intended use​
3. Both products already have their UDIs, and we wouldn't be able to apply two Basic UDI-DI to the same single UDIs​
4. It doesn't seem right that the LM would need a SRN for the legal manufacturing activity plus system producer (terminology from MDCG 2018-3, Oct-2018)​
5. I read a good position statement online that referred back to a ruling by a German regional council looking at a similar situation in Germany, where they didn't have to prepare the combination statement (MDD Art 12) because the products have already undergone conformity assessment by the NB. Thus they consider the declaration as the party for assembly of the system necessary only if they are not the legal manufacturer.​
What I am trying to avoid is putting another UDI on the box in which the product is supplied to the customer in.

Does anybody have experience with Article 22? or agreement/disagreement with my assessment above.
Really appreciate any help,
Alice
Hi Alice, were you able to obtain any clarification? It would be much appreciated, I find myself in a similar predicament. Thank you
 

mboynton

Starting to get Involved
#9
I would argue that because the two devices are not CE-marked outside of this intended use context, for use together, (i.e., not already CE-marked, as a device to be used on its own separately), that this scenario could fall within the meaning of Article 22, section 4. (Even though the devices are being CE-marked separately in the OP's status quo, maybe that is not the most natural classification scheme).

"Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manufacturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers."

Whether the Art 22 (4) treatment for the system hangs together also probably depends on how the manufacturers' documentation is structured. In the OP's scenario, having separate DoC's would seem not to align with the Art 22 (4) approach.

It seems like this may interpretation also align in spirit with OP's item #5 about the position statement (would be interested to see that reference!) where Art. 22 in general does not apply to the legal manufacturer of devices used together, although Art 22 (4) may be a more limiting means by which to reach that conclusion (does not apply to legal manufacturers when they do not separately/independently CE-mark the product outside of this intended use context), compared to a blanket ruling that it does not apply to legal manufacturers, full stop.

Where Art 22 (4) approach may start to unravel is with Annex VIII, 3.2, "If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices..."

If the system is the device, in the sense of Art 22 (4), then this provision would not seem to apply, and the entire system would have a common classification (apply the classification rules to the system components collectively). Obvious downside there is up-classifying the Class IIb component, since the OP classification structure with Class III and Class IIb components must be leveraging this provision.

However, if the components are themselves the devices intended to be used together (in the sense of Annex VIII), then the system is no longer being treated as a single device in its own right --> Article 22 (4) no longer seems to apply --> we may be back to square one, where the other Art 22 requirements would seem to apply again.
 
Thread starter Similar threads Forum Replies Date
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
S Summary of safety and clinical performance and Article 120(3) of the MDR EU Medical Device Regulations 4
E Article 17 MDR - (Re-)Processing EU Medical Device Regulations 0
H Article 22 MDR System EU Medical Device Regulations 16
F MDR – Article 120 – Transitional provisions EU Medical Device Regulations 8
H MDR Article 13(c) EU Medical Device Regulations 6
S MDR - System and procedure pack article 22 and all sub processes that apply ISO 13485:2016 - Medical Device Quality Management Systems 0
R EU-MDR Article 9-common specifications Other ISO and International Standards and European Regulations 2
M Examples of Combination Products - MDR Article 1 (8) and MDR Article 1(9) Medical Device and FDA Regulations and Standards News 3
U MDD Article 12/ MDr Article 22 interpretation EU Medical Device Regulations 2
M MDR Article 22 Interpretation EU Medical Device Regulations 3
L EU MDR Article 86 PSUR EU Medical Device Regulations 1
R Requirements for MDR Article 22 Systems EU Medical Device Regulations 1
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 9
S Article 61 - MDR Clinical Investigation Requirement EU Medical Device Regulations 9
C Article 16 MDR - Medicine packaged together with Medical Device EU Medical Device Regulations 0
F MDR system/procedurepack (article 22) with device acc. to MDD and MDR CE Marking (Conformité Européene) / CB Scheme 2
N EUDAMED postponement and compliance with Article 120 (3) MDR for Legacy Devices EU Medical Device Regulations 10
R MDR Article 22: Systems and procedure packs Other Medical Device Regulations World-Wide 12
T EU MDR Article 61- Clinical Evaluation EU Medical Device Regulations 2
M Informational EU – MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person re Medical Device and FDA Regulations and Standards News 7
F Interpretation of MDR 2017/745 Article 23 - CE Mark Requirements EU Medical Device Regulations 8
E MDR Article 117 / Impact to New Marketing Authorization Applications Other Medical Device Regulations World-Wide 1
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
T MDR article 22 - System of 2 CE products and validation / usability? EU Medical Device Regulations 10
T Clarification on MDR - Article 18(d) - Implant Card EU Medical Device Regulations 14
M Is MDR Article 61(5) Unrealistic? EU Medical Device Regulations 11
D Responsible for regulatory compliance (Article 15 of MDR 2017/745) Quality Manager and Management Related Issues 4
S EU MDR - Liability Clause per article 31 EU Medical Device Regulations 22
B MDR Technical Structure EU Medical Device Regulations 3
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
L Configurable UDI mdr EU Medical Device Regulations 0
O EU MDR labels EU Medical Device Regulations 0
M MD Class I transition period MDD to MDR - changes? EU Medical Device Regulations 1
C UDI for consumable/replacement components under the MDR EU Medical Device Regulations 2
L REACH compliance with MDR EU Medical Device Regulations 4
L EU MDR Ramifications for no expiration date on labeling EU Medical Device Regulations 1
R How to obtain OBL licence under Indian MDR, 2017 Other Medical Device Related Standards 2
Ed Panek Auditor MDR (Presub audit) finding EU Medical Device Regulations 2
M Classification of Instruments under EU MDR EU Medical Device Regulations 1
M Procedure for vigilance system according to new MDR EU Medical Device Regulations 0
M Procedure for clinical evaluation according to new MDR EU Medical Device Regulations 1
R MEDDEV 2.12-1 rev 8 (Vigilance guidelines) still applicable with the MDR implementation? EU Medical Device Regulations 1
S Determining a device category according to the MDR EU Medical Device Regulations 3
A Transactions under MDR Medical Device and FDA Regulations and Standards News 3
H Has anyone undergone MDR FQA review yet? EU Medical Device Regulations 10
S UK MDR + EU MDR Declaration of Conformity UK Medical Device Regulations 1
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1

Similar threads

Top Bottom